S-Core™ - 4mm x 5mm Drill - SUBCHONDRAL SOLUTIONS, INC.

Duns Number:117417828

Device Description: 4mm x 5mm Drill

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More Product Details

Catalog Number

10-0004

Brand Name

S-Core™

Version/Model Number

10-0004

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K162171

Product Code Details

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Device Record Status

Public Device Record Key

ff77d636-965c-4d9c-bb52-c0fdf7e37220

Public Version Date

May 16, 2022

Public Version Number

1

DI Record Publish Date

May 06, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SUBCHONDRAL SOLUTIONS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 59